Category — Pharmaceutical

This conference, supported by industry opinion leaders and exhibitors will take place in Paris January 21, 22, 2009.

The event provides a unique opportunity to not only update on state of the art scientific developments but also to do business with like minded people in the drug packaging and drug delivery business.

The location is LA GRANDE HALLE DE LA VILLETTE – HALL Charlie Parker.

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A team lead by Kimberly Hamad-Schifferli, assistant professor of biological and mechanical engineering at MIT has discovered a method to use gold particles and infrared to release multiple drugs in a systematic and controlled manner.

This is of particular importance when treating diseases like cancer and AIDS which require multi drug and coordinated dosage cocktails.

The new technique takes advantage of the fact that when gold nano particles are exposed to infrared light, they melt and release drug payloads attached to their surfaces.

Nanoparticles of different shapes respond to different infrared wavelengths, so “just by controlling the infrared wavelength, we can choose the release time” for each drug, said Andy Wijaya, graduate student in chemical engineering and lead author of the paper.

More information from MIT is available here with an interesting diagram here.

South Africa has the dubious privilege of being the worlds most populous nation per capita to be infected with the HIV virus. For years the Mbeki regime decided to go against leading researchers and continuously questioned the connection between the HIV virus and it’s natural vulgar and deadly path to AIDS. They shunned anti retro viral (ARV) programs and rather advocated healthy diet as a remedy. There was recently a change with Mbeki leaving and his successor appointing a new Health Minister Barbara Hogan who fortunately has taken a different position and has started talking about taking a much more proactive stand against the disease.

All the major pharmaceutical companies have corporations in South Africa, the major charities, including Gates and Clinton are supplying funding and support to turn around the years of aids denialism in the country and get infected patients on to ARV’s.

Just in case you need more convincing the life expectancy is down to about 48 and this is what the CIA Factbook says about the population:

48,782,756
note: estimates for this country explicitly take into account the effects of excess mortality due to AIDS; this can result in lower life expectancy, higher infant mortality, higher death rates, lower population growth rates, and changes in the distribution of population by age and sex than would otherwise be expected (July 2008 est.)

So what’s the point you may ask. Well today one of the largest provincial authorities (government funded) in the country announced that they we not taking on an new ARV treatment patients because they had run out of money – no they haven’t.

So when bureaucrat Elke de Witt says:

“Stocks must run out if you do not have money to replenish them.”

it is really time for Minister Hogan to get on a plane and take action to stop the carnage.

Money is available – They still don’t take the disease seriously.

There is an interesting article in PharmaLive which suggests that physicians are more satisfied now than before with the lower frequency of sales calls.

In data published by SDIHealth, Pfizer was ranked number 1 in traditional detailing.

Actually very few physicians or other health care professional object to sales calls as long as the calls are informative and helpful.

There are those that say that medical sales reps are going to go the way of newspapers and televisons as a result of the current new media communications methods.

It’s time to start a Facebook detailing application…

Sales force expert Jim McLean has written these interesting articles about Sales.

There is no doubt that the economic recession which has now touched all parts of the world is taking it’s toll on most industries.

One of the most resilient however is the healthcare industry. Sibaya LifeScience! recently interviewed several companies supplying services to “big pharma” in the form of contract manufacturing – especially drug delivery – at ICSE, P-Mec, Cphi – Frankfurt, Germany. While this was not a scientific study, anecdotally we were told that it was business as usual, in fact for some, business was clearly on the increase as manufacturing was being outsourced to contract manufacturers.

Not the case though for small and medium sized biotech companies according to this report in the IHT which lists companies in the Biotech hub in Massachusetts struggling for cash and laying off employees. Biotech companies need cash to fund research while waiting for their revenues to hopefully arrive one day, but in the US biotech companies have only been able to raise about half of what they did in the prior year.Technorati Tags: biotech, contract manufacturing

The United States FDA has just issued a new

Guidance for Industry: Process Validation: General Principles and Practices

This is an important new proposed guideline document and the FDA is inviting comments within 60 days of it being published in the register.

Our initial observations at Sibaya LifeScience! are:

Aligning process validation activities with the product lifecycle concept and with existing FDA guidance, this guidance now includes biological products and active pharmaceutical ingredients.

It also specifically provides recommendations with the Risk-Based Approach for technological advances in pharmaceutical manufacturing.

It clearly defines process validation ‘as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products’

From our perspective one of the most interesting guidance points is the consideration of having an integrated team composed of a variety of specialties to cover process knowledge, facility design and equipment selection among others.

The full text is available from the FDA or it is available as a PDF file from their site.

We would be interested in your views which you can add below by clicking on the comments link.

(Here is a good example of how robotics in Lifesciences can both increasingly achieve cost efficiencies but also enhanced safety and regulatory compliance (see previous post from Sibaya at Emballage 2008.)

Health Robotics and Devon International Group have entered into an agreement where DIG and ITOCHU have acquired substantial exclusive manufacturing, marketing and other rights to the Cytocare(TM) automated  robotic system for the safe preperation of specifically targetted (and hazardous) medications for oncology patients. It can also produce Monoclonal Antibodies Therapy IV Admixtures for several other diseases.

Full press release can be found here:

Health Robotics to Launch i.v.STATION(TM) Robot at ASHP and Kick-off 12 Global Beta Installations Next Week

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